Bateman Upf II Hip Prosthesis System
FDA 510(k) K895120 · 3M Company
510(k) numberK895120
Submission
- Device name
- Bateman Upf II Hip Prosthesis System
- Applicant
- 3M Company
Cottae Grove, MN, US - Received
- August 15, 1989
- Decision date
- January 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
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Questions and answers
When was Bateman Upf II Hip Prosthesis System cleared by the FDA?
Bateman Upf II Hip Prosthesis System (K895120) received a 510(k) decision of Substantially Equivalent on January 11, 1990, 149 days after the submission was received.
What is the product code of K895120?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.